Vietnam’s Ministry of Health (MoH) issued Circular No. 01/2018/TT-BYT (Circular 01) on January 18, 2018, regarding regulations on labeling of pharmaceutical products. The Circular 01 will replace current regulation Circular No. 06/2016/TT-BYT (Circular 06) and will be in effect from June 1, 2018.
The recent Circular includes guidelines regarding:-
- Labels of finished product drugs and drug raw materials;
- Package inserts of finished drugs; and
- Change in the shelf life indicated on the label of finished drugs in certain cases.
Finished drugs packaged inserts
Package insert contains detailed drug information compiled and distributed by the drug manufacturer. Its purpose is to provide a complete prescribing and safety information to health professionals. As of now, the package insert (PI) includes two separate sections, each with information for healthcare professionals and patients.
Now, as per Circular 01, it will include only one section with information for both patients and healthcare professionals.
Replacement of PI after import
As per current regulations, once a finished drug is imported in Vietnam, the PI cannot be supplemented or replaced. However, under the new regulations, this condition has been removed, allowing a PI to be replaced or supplemented in Vietnam under certain conditions such as:
- Drugs imported with Marketing Authorization (MA) licenses having Vietnamese-language PIs, but not updated as per MoH guidelines; and
- Drugs imported with import licenses without Vietnamese-language PIs.
Under Circular 01, offshore manufacturers will not be responsible for labeling.
- In the case of a drug with MA license, the importer and MA holder will be responsible. As per current regulations, both the manufacturer and the MA holder are responsible.
- For drugs with an import license, only the importer will be responsible. As of now, the manufacturer is also responsible.
Circular 01 will be in effect from June 1, 2018. As of now, drugs granted registration certificates or import permits before the effective date of the Circular, can be sold with MoH approved labels and PIs until the expiry of MA license.
Applicants who have submitted drug registration or import dossiers to the Drug Administration of Vietnam (DAV) before June 1, 2018, and awaiting approval, can submit additional dossiers to the MoH requesting to update the information on drug labels and instructions in accordance with the provisions of Circular 01. If updated documents are not submitted, the label and PI will be considered as per current regulations in Circular 06. However, once the license is issued, the license holder must update the label contents and use instructions as prescribed under Circular 01 within six months from the date of issue of the MA license.
Vietnam Briefing is published by Asia Briefing, a subsidiary of Dezan Shira & Associates. We produce material for foreign investors throughout Eurasia, including ASEAN, China, India, Indonesia, Russia & the Silk Road. For editorial matters please contact us here and for a complimentary subscription to our products, please click here.
Dezan Shira & Associates provide business intelligence, due diligence, legal, tax and advisory services throughout the Vietnam and the Asian region. We maintain offices in Hanoi and Ho Chi Minh City, as well as throughout China, South-East Asia, India, and Russia. For assistance with investments into Vietnam please contact us at firstname.lastname@example.org or visit us at www.dezshira.com
Dezan Shira & Associates Brochure
Dezan Shira & Associates is a pan-Asia, multi-disciplinary professional services firm, providing legal, tax and operational advisory to international corporate investors. Operational throughout China, ASEAN and India, our mission is to guide foreign companies through Asia’s complex regulatory environment and assist them with all aspects of establishing, maintaining and growing their business operations in the region. This brochure provides an overview of the services and expertise Dezan Shira & Associates can provide.
An Introduction to Doing Business in Vietnam 2017
An Introduction to Doing Business in Vietnam 2017 will provide readers with an overview of the fundamentals of investing and conducting business in Vietnam. Compiled by Dezan Shira & Associates, a specialist foreign direct investment practice, this guide explains the basics of company establishment, annual compliance, taxation, human resources, payroll, and social insurance in this dynamic country.
Managing Contracts and Severance in Vietnam
In this issue of Vietnam Briefing, we discuss the prevailing state of labor pools in Vietnam and outline key considerations for those seeking to staff and retain workers in the country. We highlight the increasing demand for skilled labor, provide in depth coverage of existing contract options, and showcase severance liabilities that may arise if workers or employers choose to terminate their contracts.